Attached files
| file | filename |
|---|---|
| 8-K - PEREGRINE PHARMACEUTICALS 8-K - Avid Bioservices, Inc. | peregrine_8k-041410.htm |
| EX-10.22 - COMMERCIAL LICENSE AGREEMENT - Avid Bioservices, Inc. | peregrine_8k-ex1022.htm |
| EX-10.23 - LICENSE AGREEMENT - Avid Bioservices, Inc. | peregrine_8k-ex1023.htm |
| EX-10.18 - AMENDMENT NO. 1 TO EXCLUSIVE PATENT LICENSE AGREEMENT - Avid Bioservices, Inc. | peregrine_8k-ex1018.htm |
| EX-10.19 - EXCLUSIVE PATENT LICENSE AGREEMENT - Avid Bioservices, Inc. | peregrine_8k-ex1019.htm |
| EX-10.24 - LICENSE AGREEMENT - Avid Bioservices, Inc. | peregrine_8k-ex1024.htm |
| EX-10.21 - NON-EXCLUSIVE CABILLY PATENT LICENSE AGREEMENT - Avid Bioservices, Inc. | peregrine_8k-ex1021.htm |
| EX-10.20 - AMENDMENT NO. 1 TO EXCLUSIVE PATENT LICENSE AGREEMENT - Avid Bioservices, Inc. | peregrine_8k-ex1020.htm |
EXCLUSIVE
PATENT LICENSE AGREEMENT
BETWEEN
THE
UNIVERSITY OF TEXAS SYSTEM
AND
PEREGRINE
PHARMACEUTICALS, INC.
TABLE OF
CONTENTS
| RECITALS | PAGE 1 | |
| 1. | EFFECTIVE DATE | PAGE 1 |
| 2. | DEFINITIONS | PAGE 1 |
| 3. | WARRANTY: SUPERIOR-RIGHTS | PAGE 3 |
| 4. | LICENSE | PAGE 3 |
| 5. | PAYMENTS AND REPORTS | PAGE 4 |
| 6. | TERM AND TERMINATION | PAGE 7 |
| 7. | INFRINGEMENT BY THIRD PARTIES | PAGE 8 |
| 8. | ASSIGNMENT | PAGE 8 |
| 9. | PATENT MARKING | PAGE 8 |
| 10. | INDEMNIFICATION AND INSURANCE | PAGE 9 |
| 11. | USE OF NAME | PAGE 9 |
| 12. | CONFIDENTIAL INFORMATION | PAGE 10 |
| 13. | PATENTS AND INVENTIONS | PAGE 10 |
| 14. | ALTERNATE DISPUTE RESOLUTION | PAGE 11 |
| 15. | GENERAL | PAGE 11 |
| SIGNATURES | PAGE 13 |
EXCLUSIVE PATENT LICENSE AGREEMENT
BETWEEN
THE UNIVERSITY OF TEXAS SYSTEM
AND
PEREGRINE
PHARMACEUTICALS, INC.
THIS
Agreement (AGREEMENT) is between the Board of Regents (BOARD) of The University
of Texas System (SYSTEM), an agency of the State of Texas, whose address is 201
West 7th
Street, Austin, Texas 78701, on behalf of The University of Texas Southwestern
Medical Center at Dallas (UT SOUTHWESTERN), a component institution of SYSTEM,
and Peregrine Pharmaceuticals, Inc. (LICENSEE), a Delaware corporation having a
principal place of business located at 14272 Franklin Avenue, Suite 100, Tustin,
California 92780.
A. BOARD
owns certain PATENT RIGHTS (as defined below) and TECHNOLOGY RIGHTS (as defined
below) related to LICENSED SUBJECT MATTER (as defined below), which were
developed at UT SOUTHWESTERN.
B. BOARD
desires to have the LICENSED SUBJECT MATTER developed and used for the benefit
of LICENSEE, INVENTORS (as defined below), BOARD, and the public as outlined in
BOARD’S Intellectual Property Policy.
C. LICENSEE
wishes to obtain a license from BOARD to practice LICENSED SUBJECT
MATTER.
NOW, THEREFORE, in
consideration of the mutual covenants and premises herein contained, the parties
agree as follows:
1. EFFECTIVE
DATE
This
AGREEMENT is effective August 18, 2005 (EFFECTIVE DATE).
2. DEFINITIONS
As used
in this AGREEMENT, the following terms have the meanings indicated:
2.1 AFFILIATE means any business
entity more than 50% owned by LICENSEE, any business entity which owns more than
50% of LICENSEE, or any business entity that is more than 50% owned by a
business entity that owns more than 50% of LICENSEE.
2.2 FDA means United States Food
and Drug Administration.
2.3 FIELD means all human
therapeutic and diagnostic uses.
2.4 INVENTOR(S) means Philip
Thorpe, Jin He, Melina Soares, Xianming Huang and Sophia Ran.
2.5 LICENSED PRODUCT means any
product or service which is covered by or is produced using LICENSED SUBJECT
MATTER pursuant to this AGREEMENT.
Page 1
of 13
2.6 LICENSED SUBJECT MATTER means
inventions, discoveries and processes covered by PATENT RIGHTS and/or TECHNOLOGY
RIGHTS within FIELD.
2.7
NET SALES means the
gross revenues received by LICENSEE, AFFILIATE and/or any sublicensee pursuant
to Paragraph 4.3 from the SALE of LICENSED PRODUCTS less, to the extent paid by
LICENSEE, AFFILIATE and/or any sublicensee: (a) cost of freight, postage, and
freight insurance; (b) sales taxes, value added taxes, excise taxes, and customs
duties; (c) cost of export licenses and any taxes, fees or other governmental
charges imposed upon the exportation or importation of LICENSED PRODUCTS; (d)
rebates accrued, incurred or paid and any price reductions required by law,
rule, regulation or any governmental agency; (e) rejected shipments, returns,
recalls and retroactive deductions; (f) customary cash, quantity, and trade
discounts; provided, however, that with respect to the deductions specified in
subsections (a) through (f) above, an amount shall be deducted only once
regardless of how many categories may apply to it. No deductions
shall be made for commissions paid to sales persons or agents or for the cost of
collections.
In the
event that LICENSED PRODUCTS are SOLD in the form of a combination product
containing one or more active ingredients other than LICENSED PRODUCTS, NET
SALES for such combination products shall be calculated by multiplying actual
NET SALES of the combination product by the fraction A/(A+B) where A is the
invoice price of the LICENSED PRODUCT if SOLD separately and B is the total
invoice price of any other active component or components in the combination if
sold separately by LICENSEE or sublicensee; provided, however that the resulting
value of such NET SALES of combination products shall not be less than 50% of
the value of the NET SALES of the LICENSED PRODUCTS had they been SOLD
separately. If, on a country-by-country basis, the LICENSED PRODUCT
and other active component or components in the combination are not SOLD
separately in any country by LICENSEE or sublicensee, NET SALES for purposes of
determining royalties on the combination product shall be calculated by
multiplying actual NET SALES of such combination product by the fraction C/(C+D)
where C is LICENSEE’S or sublicensee’s total actual cost of the LICENSED PRODUCT
and D is the total actual cost of the other active ingredient(s) included in the
combination product at such point; provided, however that the resulting value of
such NET SALES of combination products shall not be less than 50% of the value
of the actual cost of the LICENSED PRODUCTS.
2.8 PATENT RIGHTS means BOARD’S
rights in the patent applications listed on Exhibit 1, the inventions described
and claimed therein, and all patents anywhere in the world that issue from
these, and any divisionals, continuations, continuations-in-part (but solely to
the extent not containing new matter), extensions (including supplemental
protection certificates), substitutions, registrations, confirmations,
re-examinations, renewals and any patents issuing on any of the foregoing, as
well as extensions and reissues thereof.
2.9 PHASE 1 CLINICAL STUDIES means
human clinical trials in any country that satisfy the requirements of U.S. 21
CFR 312.21(a) or its non-U.S. equivalent.
2.10
PHASE 2 CLINICAL STUDIES means
human clinical trials in any country that satisfy the requirements of U.S. 21
CFR 312.21(b) or its non-U.S. equivalent.
2.11
PHASE 3 CLINICAL STUDIES means
human clinical trials in any country that satisfies the requirements of U.S. 21
CFR 312.21(c) or its non-U.S. equivalent.
2.12
SALE, SELL or SOLD means the
transfer or disposition of a LICENSED PRODUCT for value to a party other than
LICENSEE, AFFILIATE and/or any sublicensee. SALE does not include
transfer or disposition of a LICENSED PRODUCT, at or below cost, for charitable,
promotional, pre-clinical, clinical, regulatory or governmental
purposes.
Page 2 of
13
2.13 TECHNOLOGY RIGHTS means
BOARD’S rights in technical information, know-how, processes, procedures,
compositions, devices, methods, formulas, protocols, techniques, software,
designs, drawings or data created by INVENTORS at UT SOUTHWESTERN before the
EFFECTIVE DATE and relating to using antibodies as treatment for viral disease
and cancer which are not covered by PATENT RIGHTS but which are necessary for
practicing the PATENT RIGHTS (UT SOUTHWESTERN file references UTSD:0892;
UTSD:0893; UTSD:0968).
3. WARRANTY:
SUPERIOR-RIGHTS
3.1
Except for the rights, if any, of the government of the United States of America
(GOVERNMENT), as set forth below, BOARD represents and warrants (1) that it is
the owner of the entire right, title, and interest in and to LICENSED SUBJECT
MATTER, (2) that it has the sole right to grant licenses thereunder, and (3) its
belief that it has not knowingly granted licenses thereunder to any other entity
that would restrict rights granted to LICENSEE except as stated
herein.
3.2 LICENSEE
understands that the LICENSED SUBJECT MATTER may have been developed under a
funding agreement with the GOVERNMENT and, if so, that the GOVERNMENT may have
certain rights relative thereto. This AGREEMENT is explicitly made
subject to the GOVERNMENT’S rights under any agreement and any applicable law or
regulation. If there is a conflict between any agreement, applicable
law or regulation and this AGREEMENT, the terms of the GOVERNMENT agreement,
applicable law or regulation shall prevail. LICENSEE agrees that
LICENSED PRODUCTS used or SOLD in the United States will be manufactured
substantially in the United States, unless a written waiver is obtained in
advance from the GOVERNMENT.
3.3
LICENSEE understands and acknowledges that BOARD, by this AGREEMENT, makes no
representation as to the operability or fitness for any use, safety, efficacy,
approvability by regulatory authorities, time and cost of development,
patentability, and/or breadth of the LICENSED SUBJECT MATTER. BOARD,
by this AGREEMENT, also makes no representation as to whether there are any
patents now held, or which will be held, by others or by BOARD which may be
dominant or subordinate to PATENT RIGHTS, nor does BOARD make any representation
that the inventions contained in PATENT RIGHTS do not infringe any other patents
now held or that will be held by others or by BOARD.
3.4 LICENSEE,
by execution hereof, acknowledges, covenants and agrees that it has not been
induced in any way by BOARD, SYSTEM, UT SOUTHWESTERN or its employees to enter
into this AGREEMENT, and further warrants and represents that (1) it has
conducted sufficient due diligence with respect to all items and issues
pertaining to this AGREEMENT; and (2) LICENSEE has adequate knowledge and
expertise, or has utilized knowledgeable and expert consultants, to adequately
conduct the due diligence, and agrees to accept all risks inherent
herein.
4. LICENSE
4.1 BOARD
hereby grants to LICENSEE a worldwide, royalty-bearing, exclusive license under
LICENSED SUBJECT MATTER to manufacture, have manufactured, use, import, offer
for SALE and/or SELL LICENSED PRODUCTS for use within FIELD. This
grant is subject to the payment by LICENSEE to BOARD of all consideration as
provided herein, and is further subject to rights retained by BOARD
to:
a. publish
the general scientific findings from research related to LICENSED SUBJECT MATTER
subject to the terms of Article 12, Confidential Information;
Page 3 of
13
b. use
LICENSED SUBJECT MATTER for research, teaching and other educationally-related
purposes; and
c. transfer
LICENSED SUBJECT MATTER to academic or research institutions for non-commercial
research use with prior written consent from LICENSEE, which consent will not be
unreasonably withheld or delayed.
4.2 LICENSEE
may extend the license granted herein to any AFFILIATE if the AFFILIATE consents
in writing to be bound by this AGREEMENT to the same extent as
LICENSEE. LICENSEE must deliver to BOARD a true and accurate copy of
such written agreement, and any modification or termination thereof, within 30
days after execution, modification or termination.
4.3
LICENSEE may grant sublicenses consistent with this AGREEMENT if LICENSEE is
responsible for all obligations under this AGREEMENT including the payment
obligations relating to sublicensees pursuant to Article 5 as if they were those
of LICENSEE, whether or not such payments are made by the sublicensee to
LICENSEE. LICENSEE must deliver to BOARD a true and correct copy of
each sublicense granted by LICENSEE, and any modification or termination
thereof, within 30 days after execution, modification, or
termination. If this AGREEMENT is terminated, BOARD and UT
SOUTHWESTERN agree to accept as successors to LICENSEE existing sublicensees in
good standing at the date of termination, provided that the sublicensees consent
in writing to be bound by all the terms and conditions of this
AGREEMENT.
5. PAYMENTS
AND REPORTS
5.1 In
consideration of rights granted by BOARD to LICENSEE under this AGREEMENT,
LICENSEE will pay BOARD the following:
a. a
non-refundable license documentation fee in the amount of $10,000.00, due and
payable within 30 days of LICENSEE’S receipt of a fully executed AGREEMENT from
BOARD;
b. an annual
license reissue fee in the amount of [***],
due and payable on each anniversary of the EFFECTIVE DATE beginning on the first
anniversary;
c.
a running royalty equal to [***] of NET SALES;
d.
milestone fees according to the table below, due and payable within 30 days of
each milestone event for a LICENSED PRODUCT:
|
Milestone
Event
|
Milestone
Fee
|
||
|
Initiation
of PHASE 1 CLINICAL STUDIES
|
[***]
|
||
|
Initiation
of PHASE 2 CLINICAL STUDIES
|
[***]
|
||
|
Initiation
of PHASE 3 CLINICAL STUDIES
|
[***]
|
||
|
Filing
of a new drug application
|
[***]
|
||
|
Regulatory
Approval
|
[***]
|
[***] The
following portion has been omitted pursuant to a Confidential Treatment Request
under Rule 24b-2 of the Securities Exchange Act of 1934 and has been filed
separately with the Securities and Exchange Commission.
Page 4 of
13
For the
purpose of this Section 5.1e, “Initiation” means the date the first patient is
dosed by or on behalf of LICENSEE;
e.
if LICENSEE is required to pay royalties to a third party under patents owned by
such third party to manufacture, have manufactured, use, import, offer for SALE
and/or SELL LICENSED PRODUCTS for use within FIELD, then LICENSEE may reduce the
royalty payment owed to BOARD on the same LICENSED PRODUCT under Section 5.1c by
[***]
of the royalty paid to such third party, but in no event shall such reduction,
alone or in combination with a reduction as described in Section 5.1f, result in
a royalty of [***]
of the royalties due pursuant to Section 5.1c;
f.
if LICENSEE is required to pay royalties on a LICENSED PRODUCT under any other
license agreement between BOARD and LICENSEE covering any patents naming Philip
Thorpe as inventor and developed at UT SOUTHWESTERN before the EFFECTIVE DATE,
then LICENSEE may reduce the royalty payment owed to BOARD on the same LICENSED
PRODUCT under Section 5.1c by [***]
paid to BOARD under such other license agreement, but in no event shall such
reduction, alone or in combination with a reduction as described in Section
5.1e, result in a royalty of less than [***]
of the royalties due pursuant to Section 5.1c;
g.
all out-of-pocket expenses paid by UT SOUTHWESTERN prior to the EFFECTIVE DATE
in filing, prosecuting and maintaining PATENT RIGHTS. All future
expenses will be paid in accordance with Paragraph 13.3;
h.
a sublicense fee of [***]
of all consideration received by LICENSEE from any sublicensee pursuant
to Paragraph 4.3 above, including but not limited to, marketing, distribution,
franchise, option, annual license or license renewal fees and bonus and
milestone payments, other than development milestones, and expressly excluding
any up-front cash payments, milestones payments for development milestone
events, including, but not limited to, those listed in Section 5.1d, royalties
on NET SALES and research and development money, within 30 days of LICENSEE’S
receipt of any such consideration. In the event any such
consideration is paid to LICENSEE in the form of equity securities, the value of
such equity securities will be calculated as the average market value of the
class of stock involved for 5 consecutive days preceding the transfer to
LICENSEE, if a public market exists for same, or if no public market exists the
price of such equity securities on the date of transfer to LICENSEE as
determined by the sublicensee's board of directors. In cases where
the sublicense or assignment agreement calls for payment to LICENSEE of a
premium over the market value, BOARD will also share [***]
of the premium paid to LICENSEE. In the event a sublicense
agreement includes the type of consideration covered under this Section 5.1h for
a combination of LICENSED SUBJECT MATTER and LICENSEE’S other technologies, the
amount due will be reasonably determined by the parties based on the relative
value of LICENSED SUBJECT MATTER and LICENSEE’S additional technology;
and
i.
a sublicense fee of [***]
of any up-front cash payment, including any initial license, license issuance or
documentation fees, or [***],
whichever is less, received by LICENSEE from any sublicensee pursuant to
Paragraph 4.3 above within 30 days of LICENSEE’s receipt of any such
consideration. For the avoidance of doubt, in the event that LICENSEE
does not receive any up-front cash payment in connection with any sublicense
agreement, [***]
shall be due by LICENSEE under this Section 5.1i. In the event a
sublicense agreement includes the type of consideration covered under this
Section 5.1i for a combination of LICENSED SUBJECT MATTER and LICENSEE’S other
technologies, the amount due will be reasonably determined by the parties based
on the relative value of LICENSED SUBJECT MATTER and LICENSEE’S additional
technology.
[***] The following portion has been omitted pursuant to a
Confidential Treatment Request under Rule 24b-2 of the Securities Exchange Act
of 1934 and has been filed separately with the Securities and Exchange
Commission.
Page 5 of
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5.2 In the
event payments to BOARD due under Article 5 are late in excess of 30 days, a
penalty equal to the lesser of 5% and the maximum rate allowed by applicable law
of the amount due will be assessed and due additionally from LICENSEE for each
such late payment, provided, however, that in the event there is a bona fide
dispute as to whether such payment is due such 30 day period shall be
tolled.
5.3 No
multiple royalties shall be payable in the event that any LICENSED PRODUCT(S) or
the manufacture, use or sale thereof is covered by more than one patent or
patent application included in the PATENT RIGHTS.
5.4
During the term of this AGREEMENT and for 1 year thereafter, LICENSEE agrees to
keep, and to require each of its sublicensees to keep, complete and accurate
records of, respectively, its and its sublicensees’ SALES and NET SALES under
the license granted in this AGREEMENT in sufficient detail to enable the
royalties payable hereunder to be determined. LICENSEE agrees to
permit an independent accounting firm selected by BOARD and approved by
LICENSEE, such approval not to be unreasonably withheld, at BOARD’s request and
expense and with 14 days written notice, to examine its books, ledgers, and
records during regular business hours, but not more than once in any 12-month
period, for the purpose of and to the extent necessary to verify any report
required under this AGREEMENT. If the amounts due to BOARD are
determined to have been underpaid by 10% or more in any given calendar quarter,
LICENSEE will pay the cost of the examination and all overdue amounts with
accrued interest at the highest allowable rate, provided that such independent
accounting firm first agrees in writing to treat all information learned in
connection with such examination as LICENSEE’s confidential information, in
accordance with Article 12 hereof.
5.5
Within 30 days after March 31, June 30, September 30, and December 31 of each
year of the valid term of this AGREEMENT, beginning immediately after the first
SALE of a LICENSED PRODUCT, LICENSEE must deliver to BOARD a true and accurate
written report, even if no payments are due BOARD, giving the particulars of the
business conducted by LICENSEE and its sublicensee(s), if any exist, during the
preceding calendar quarter under this AGREEMENT as are pertinent to calculating
payments hereunder. Such reports will be on a per-country and
per-product basis and presented substantially in the form as shown in the
attached Exhibit 2. Simultaneously with the delivery of each report,
LICENSEE must pay to BOARD the amount due, if any, for the period of each
report.
5.6
On or before January 1 of each year, irrespective of having a first SALE or
offer for SALE, LICENSEE must deliver to BOARD a written progress report as to
LICENSEE’S (and any sublicensee’s) efforts and accomplishments during the
preceding year in diligently commercializing LICENSED SUBJECT MATTER and
LICENSEE’S (and sublicensee’s) commercialization plans for the upcoming
year.
5.7 All
amounts payable under this AGREEMENT by LICENSEE must be paid in United States
dollars without deductions for taxes, assessments, fees, or charges of any kind
(except such deductions as are expressly permitted in accordance with the
definition of NET SALES). Royalties accruing on SALES in countries
other than the United States must be paid in United States dollars in amounts
based on the rate of exchange as quoted in the Wall Street Journal (“WSJ”) as of
the last business day of the reporting period. If the WSJ does not
publish any such rate, a comparable rate publication will be agreed upon from
time to time by the parties, and with respect to each country for which such
rate is not published by the WSJ or in a comparable publication, the parties
will use the prevailing rate for bank cable transfers for such date, as quoted
by leading United States banks in New York City dealing in the foreign exchange
market.
Page 6 of
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5.8 All
payments must be payable to UT SOUTHWESTERN and sent to the address listed in
Paragraph 15.2.
6. TERM
AND TERMINATION
6.1 The term
of this AGREEMENT shall commence on the EFFECTIVE DATE, and this AGREEMENT shall
continue in full force and effect, on a country-by-country, LICENSED
PRODUCT-by-LICENSED PRODUCT basis, until the later of (i) the final abandonment
of all pending patent applications within the PATENT RIGHTS, or (ii) the
expiration of the last to expire patent within the PATENT RIGHTS.
6.2
Any time after 3 years from the EFFECTIVE DATE, BOARD and UT SOUTHWESTERN have
the right to terminate this license in any national political jurisdiction if
LICENSEE, within 90 days after receiving written notice from UT SOUTHWESTERN of
the intended termination, fails to provide written evidence reasonably
satisfactory to UT SOUTHWESTERN that LICENSEE or its sublicensee(s)
has:
a. SALES in
such jurisdiction; or
b. an
effective, ongoing and active research, development, manufacturing, marketing or
sales program as appropriate, directed toward obtaining regulatory approval,
and/or production and/or SALES in any jurisdiction in accordance with LICENSEE’S
business, legal, medical and scientific judgment and LICENSEE’S normal practices
and procedures for products having similar technical and commercial
potential.
6.3 This
AGREEMENT will earlier terminate:
a. automatically
if LICENSEE becomes bankrupt and/or if the business of LICENSEE is placed in the
hands of a receiver, assignee, or trustee, whether by voluntary act of LICENSEE
or otherwise; or
b. upon 7
days written notice from BOARD if LICENSEE becomes insolvent unless, before the
end of the 7 day period, LICENSEE provides BOARD with evidence of its solvency
(for the purposes of this Section 6.3b, the term “insolvent” means substantially
unable to pay its debts when they come due continuing for a period of 60 days or
longer, and expressly excludes the failure to pay such debts for any other
reason such as a billing discrepancy or a bona fide dispute); or
c. upon 30
days written notice from BOARD if LICENSEE breaches or defaults on its
obligation to make payments (if any are due) or reports, in accordance with the
terms of Article 5 hereunder, unless, before the end of the 30 day period,
LICENSEE has cured the breach or default and so notifies BOARD, stating the
manner of the cure; or
d. upon 90
days written notice if LICENSEE breaches or defaults on any other obligation
under this AGREEMENT, unless, before the end of the 90 day period, LICENSEE has
cured the breach or default and so notifies BOARD, stating the manner of the
cure; or
Page 7 of
13
e. at any
time by mutual written agreement between LICENSEE, UT SOUTHWESTERN and BOARD and
subject to any terms herein which survive termination unless otherwise agreed by
the parties in writing; or
f. at any
time by LICENSEE upon 90 days written notice to all parties and subject to any
terms herein which survive termination; or
g. under the
provisions of Paragraph 6.2 if invoked.
6.4 Unless
otherwise agreed by the parties in writing, if this AGREEMENT is terminated for
any reason:
a. nothing
herein will be construed to release either party of any obligation matured prior
to the effective date of the termination;
b. after the
effective date of the termination, LICENSEE will provide BOARD with a written
inventory of all LICENSED PRODUCTS in process of manufacture, in use or in
stock. LICENSEE, AFFILIATE or any sublicensee may SELL any such
LICENSED PRODUCTS within the 90 day period following such termination if
LICENSEE pays earned royalties thereon, and any other amount due pursuant to the
terms of Article 5; and
c. Each
party, as applicable, will be bound by the provisions of Articles 10
(Indemnification And Insurance), 11 (Use Of Name), and 12 (Confidential
Information) of this AGREEMENT.
7. INFRINGEMENT
BY THIRD PARTIES
7.1 LICENSEE,
at its expense, may enforce PATENT RIGHTS against infringement in the FIELD by
third parties and is entitled to retain recovery from such enforcement,
provided, however, that after LICENSEE recovers it reasonable out-of-pocket
legal expenses incurred in such enforcement, any recovery for actual damages or
a reasonable royalty in lieu thereof will be considered NET SALES and subject to
royalty payments pursuant to Section 5.1c. If LICENSEE does not file
suit against a substantial infringer of PATENT RIGHTS within 6 months of
knowledge thereof and has not entered into good faith negotiations to sublicense
such infringer, and such infringement has not otherwise ceased, then BOARD may
enforce PATENT RIGHTS on behalf of itself and LICENSEE at BOARD’S sole expense,
BOARD retaining all recoveries from such enforcement and/or reducing the license
granted hereunder to non-exclusive with respect to the relevant
patent(s).
7.2 In any
infringement suit or dispute, the parties agree to cooperate fully with each
other. At the request and expense of the party bringing suit, the
other party will permit access to all relevant personnel, records, papers,
information, samples, specimens, etc., during regular business
hours.
8. ASSIGNMENT
Except in
connection with a merger, consolidation, reorganization or acquisition, or the
sale of all, or substantially all, of LICENSEE’S assets to which this AGREEMENT
relates to a third party with written notice to UT SOUTHWESTERN, LICENSEE may
not assign this AGREEMENT without the prior written consent of BOARD, which will
not be unreasonably withheld.
9. PATENT
MARKING
LICENSEE
must permanently and legibly mark all products, packaging and documentation
manufactured or SOLD by it under this AGREEMENT with a patent notice as may be
permitted or required under Title 35, United States Code.
Page 8 of
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10. INDEMNIFICATION
AND INSURANCE
10.1
LICENSEE agrees to hold harmless and indemnify BOARD, INVENTORS, SYSTEM, UT
SOUTHWESTERN, its Regents, officers, employees and agents (collectively,
“Indemnitees”) from and against any claims, demands, or causes of action
whatsoever, relating to this AGREEMENT, brought by any third party, including
without limitation those arising on account of any injury or death of persons or
damage to property caused by, or arising out of, or resulting from, the exercise
or practice of the license granted hereunder by LICENSEE, its AFFILIATES or
their officers, employees, agents or representatives. The obligations
of LICENSEE stated in this Paragraph 10.1 shall apply only if an Indemnitee
promptly notifies LICENSEE in writing following receipt of written notice of any
claim or suit brought against Indemnitee in respect of which Indemnitee intends
to invoke the provisions of this Paragraph 10.1. Subject to the
statutory duties of the Texas Attorney General, LICENSEE shall have the right to
control the defense of any such action, including the right to select counsel to
defend an Indemnitee and LICENSEE and to settle any claim or suit with the
approval of SYSTEM and UT SOUTHWESTERN, which approval will not be unreasonably
withheld, conditioned or delayed. LICENSEE shall keep the Indemnitee
informed on a regular basis of its defense of any claims pursuant to this
Paragraph 10.1.
10.2 Beginning
at the time when any LICENSED PRODUCT is being distributed or SOLD (including
for the purpose of obtaining regulatory approvals) by LICENSEE or by a
sublicensee, LICENSEE will, at its sole cost and expense, procure and maintain
commercial general liability insurance in amounts not less than $2,000,000 per
incident and $2,000,000 annual aggregate, and LICENSEE will use reasonable
efforts to have the BOARD, SYSTEM, UT SOUTHWESTERN, its officers, employees and
agents named as additional insureds. Such commercial general
liability insurance will provide (i) product liability coverage; (ii) broad form
contractual liability coverage for LICENSEE’S indemnification under this
AGREEMENT; and (iii) coverage for litigation costs. The minimum
amounts of insurance coverage required will not be construed to create a limit
of LICENSEE’S liability with respect to its indemnification under this
AGREEMENT.
10.3 LICENSEE
will provide BOARD with written evidence of such insurance upon BOARD’S
request. LICENSEE will provide BOARD with written notice of at least
15 days prior to the cancellation, non-renewal or material change in such
insurance.
10.4 LICENSEE
will maintain such commercial general liability insurance beyond the expiration
or termination of this AGREEMENT during (i) the period that any LICENSED PRODUCT
developed pursuant to this AGREEMENT is being commercially distributed or SOLD
by LICENSEE or by a sublicensee or agent of LICENSEE; and (ii) the 5 year period
immediately after such period.
11. USE
OF NAME
LICENSEE
may not use the name of UT SOUTHWESTERN, SYSTEM, INVENTORS or BOARD without
express written consent from the respective party except as required by
governmental law, rule or regulation. Consent for UT SOUTHWESTERN,
SYSTEM and/or BOARD should be requested in writing at least 5 business days in
advance and sent to:
Roy
Bode
Vice
President for Public Affairs
UT
Southwestern Medical Center at Dallas
5323
Harry Hines Blvd.
Dallas,
Texas 75390-8588
Email: Roy.Bode@UTSouthwestern.edu
Phone: 214-648-7500
Fax: 214-648-7503
Page 9 of
13
12. CONFIDENTIAL
INFORMATION
12.1 The
parties agree that all information forwarded to one by the other for the
purposes of this AGREEMENT (1) are to be received in strict confidence, (2) are
to be used only for the purposes of this AGREEMENT, and (3) are not to be
disclosed by the recipient party, its agents or employees without the prior
written consent of the other party, except to the extent that the recipient
party can establish competent written proof that such information:
a. was in
the public domain at the time of disclosure;
b. later
became part of the public domain through no act or omission of the recipient
party, its employees, agents, successors or assigns;
c. was
lawfully disclosed to the recipient party by a third party having the right to
disclose it;
d. was
already known by the recipient party prior to disclosure by the disclosing
party;
e. was
independently developed by the recipient; or
f. is
required by law or regulation to be disclosed, provided however, that the
disclosing party shall first give the other party written notice and adequate
opportunity to object to such order for disclosure or to request confidential
treatment.
12.2 Information
shall not be deemed to be available to the public or to be in the recipient’s
possession merely because it:
a. includes
information that falls within an area of general knowledge available to the
public or to the recipient (i.e., it does not include the specific information
provided by the other party); or
b. can be
reconstructed in hindsight from a combination of information from multiple
sources that are available to the public or to the recipient, if not one of
those sources actually taught or suggested the entire combination, together with
its meaning and importance.
12.3 Each
party’s obligation of confidence hereunder shall be fulfilled by using at least
the same degree of care with the other party’s confidential information as it
uses to protect its own confidential information, but in no event less than a
reasonable degree of care. This obligation shall exist while this
AGREEMENT is in force and for a period of 3 years thereafter.
13. PATENTS
AND INVENTIONS
13.1 BOARD, UT
SOUTHWESTERN and LICENSEE will select the patent attorney, patent agent and/or
law firm responsible for searching, filing, prosecuting and maintaining patent
applications and patents for LICENSED SUBJECT MATTER, such attorney, agent
and/or law firm to be reasonably acceptable to BOARD, UT SOUTHWESTERN and
LICENSEE.
Page 10 of
13
13.2 If after
consultation, both parties agree that a patent application should be filed for
LICENSED SUBJECT MATTER, BOARD will authorize the preparation and filing of the
appropriate patent application and such application will be considered PATENT
RIGHTS. If LICENSEE does not respond or make an effort to agree with
BOARD on the disposition of rights in the subject invention, then BOARD may file
an application at its own expense and LICENSEE will have no rights to such
invention or any patent application or resulting patents.
13.3 LICENSEE
will directly pay all costs for searching, filing, prosecuting and maintaining
PATENT RIGHTS that accrue after the EFFECTIVE DATE. Unless LICENSEE
is handling such matters internally using its own employees, consultants or
agents, LICENSEE will provide UT SOUTHWESTERN with evidence of payment of such
costs within 30 days of LICENSEE’S receipt of invoices. LICENSEE will
notify UT SOUTHWESTERN if it does not intend to pay any such costs at least 90
days prior to the deadline for such payment. If LICENSEE (1) notifies
BOARD that it does not intend to pay costs associated with any patent
application and/or patent under PATENT RIGHTS; or (2) fails to pay costs in a
timely manner, then LICENSEE will have no further rights under this AGREEMENT to
such patent application and/or patent.
13.4 LICENSEE
will arrange to provide UT SOUTHWESTERN a copy of all patent applications filed
for LICENSED SUBJECT MATTER for which LICENSEE has paid the cost as well as
copies of any patent related communications, including, but not limited to,
office actions, responses and, if applicable, invoices. The parties
each have the right to review and comment upon the wording of specifications,
claims and responses to office actions prior to their submission to the
appropriate patent office.
14. ALTERNATE
DISPUTE RESOLUTION
Any
dispute or controversy arising out of or relating to this AGREEMENT, its
construction or its actual or alleged breach will be decided by
mediation. If the mediation does not result in a resolution of such
dispute or controversy, it will be finally decided by an appropriate method of
alternate dispute resolution, including without limitation, arbitration,
conducted in the city of Dallas, Texas in accordance with the Commercial
Arbitration Rules and Mediation Procedures of the American Arbitration
Association. The arbitration panel will include members knowledgeable
in the evaluation of biotechnology. Judgment upon the award rendered
may be entered in the highest court or forum having jurisdiction, state or
federal. The provisions of this Article 14 will not apply to
decisions on the validity of patent claims or to any dispute or controversy as
to which any treaty or law prohibits such arbitration. The decision
of the arbitration must be sanctioned by a court of law having jurisdiction to
be binding upon and enforceable by the parties.
15. GENERAL
15.1 This
AGREEMENT constitutes the entire and only agreement between the parties for
LICENSED SUBJECT MATTER and all other prior negotiations, representations,
agreements, and understandings are hereby superseded. No agreements
altering or supplementing these terms may be made except by a written document
signed by both parties.
15.2
Any payments required by this AGREEMENT must be payable to UT SOUTHWESTERN and
sent to:
UT
Southwestern Medical Center at Dallas
Office
for Technology Development
5323
Harry Hines Boulevard
Dallas,
Texas 75390-9094
ATTENTION: Director
for Technology Transfer
Page 11 of
13
15.3 Any
notice required by this AGREEMENT must be given by email or facsimile
transmission confirmed by personal delivery (including delivery by reputable
courier services such as Federal Express) or by prepaid, first class, certified
mail, return receipt requested, addressed in the case of BOARD and UT
SOUTHWESTERN to:
UT
Southwestern Medical Center at Dallas
Office
for Technology Development
5323
Harry Hines Boulevard
Dallas,
Texas 75390-9094
ATTENTION: Director
for Technology Transfer
Email: TechnologyDevelopment@UTSouthwestern.edu
Phone: (214)
648-1888
Fax: (214)
648-1889
or in the
case of LICENSEE to:
Peregrine
Pharmaceuticals, Inc.
14272
Franklin Avenue, Suite 100
Tustin,
California 92780
ATTENTION: Steven
King, Ph.D.
Email: sking@peregrineinc.com
Phone: (714)
508-6000
Fax: (714)
838-5817
or other
addresses as may be given from time to time under the terms of this notice
provision.
15.4 LICENSEE
must comply with all applicable national, state and local laws and regulations
in connection with its activities pursuant to this AGREEMENT.
15.5 This
AGREEMENT will be construed and enforced in accordance with the laws of the
United States of America and of the State of Texas. The Texas state
courts of Dallas County, Texas (or, if there is exclusive federal jurisdiction,
the United States District Court for the Northern District of Texas) shall have
exclusive jurisdiction and venue over any dispute arising out of this AGREEMENT,
and LICENSEE hereby consents to the jurisdiction of such courts.
15.6 Failure
by either party to enforce a right under this AGREEMENT will not act as a waiver
of that right or the ability to later assert that right relative to the
particular situation involved.
15.7 Headings
are included herein for convenience only and shall not be used to construe this
AGREEMENT.
15.8 If any
part of this AGREEMENT is for any reason found to be unenforceable, all other
parts nevertheless remain enforceable.
THE
REMAINDER OF THIS PAGE IS INTENTIONALLY BLANK
Page 12 of
13
15.9 Neither
party shall be held liable or responsible to the other party nor be deemed to
have defaulted under or breached this AGREEMENT for failure or delay in
fulfilling or performing any term of this AGREEMENT when such failure or delay
is caused by or results from causes beyond the reasonable control of the
affected party, including, without limitation, fire, floods, earthquakes,
natural disasters, embargoes, war, acts of war (whether war is declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority.
IN WITNESS WHEREOF, the
parties hereto have caused their duly authorized representatives to execute this
AGREEMENT.
|
THE
UNIVERSITY OF TEXAS SYSTEM
|
PEREGRINE
PHARMACEUTICALS, INC.
|
|
By /s/ John
A.
Roan
|
By /s/
Steven W.
King
|
|
John
A. Roan
|
Steven
W. King
|
|
Executive
Vice President for Business Affairs
|
President
and CEO
|
|
UT
Southwestern Medical Center at Dallas
|
|
|
Date
9-3-05
|
Date 29 August
2005
|
|
Approved
as to Content:
|
|
By /s/ Dennis
K.
Stone
|
|
Dennis
K. Stone, M.D.
|
|
Vice
President for Technology Development
|
|
UT
Southwestern Medical Center at Dallas
|
|
Date
9/2/05
|
Page 13 of
13
EXHIBIT 1
PATENT
RIGHTS
a. U.S.
Provisional Patent Application Number 60/396,263, filed July 15, 2002, now
lapsed, entitled “Antibodies and Peptides Binding to Anionic Phospholipids and
Aminophospholipids and Their Use in Viral Inhibition & Disease Treatment”
(UT SOUTHWESTERN file reference UTSD:0892 PZ1);
b. U.S.
Patent Application Number 10/642,120, filed August 15, 2003, entitled “Methods
For Treating Viral Infections Using Antibodies To Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD:0892 US);
c. U.S.
Patent Application Number 10/642,060, filed August 15, 2003, entitled
“Combinations and Kits for Treating Viral Infections Using Antibodies to
Aminophospholipids” (UT SOUTHWESTERN file reference UTSD:0892-1
US);
d. U.S.
Patent Application Number 10/642,119, filed August 15, 2003, entitled “Methods
for Treating Viral Infections Using Immunoconjugates to Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD:0892-2 US);
e. U.S.
Patent Application Number 10/642,124, filed August 15, 2003, entitled
“Compositions for Treating Viral Infections Using Immunoconjugates to
Aminophospholipids” (UT SOUTHWESTERN file reference UTSD:0892-3
US);
f. U.S.
Patent Application Number 10/642,122, filed August 15, 2003, entitled
“Combinations and Kits for Treating Viral Infections Using Immunoconjugates To
Aminophospholipids” (UT SOUTHWESTERN file reference UTSD:0892-4
US);
g. Australian
Patent Application Number 2003247869, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 AU);
h. Brazilian
Patent Application Number PI0312692-7, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 BR);
i. Canadian
Patent Application Number 2,491,310, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 CA);
j. Chinese
Patent Application Number 03816751.4, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 CN);
k. European
Patent Application Number 03764600.7, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 EP);
Exhibit 1
Page 1 of 3
l. Hong Kong
Patent Application, based upon European Patent Application Number 03764600.7,
effective filing date July 15, 2003, entitled “Selected Antibodies and Duramycin
Peptides Binding to Anionic Phospholipids and Aminophospholipids and Their Use
in Treating Viral Infections and Cancer” (UT SOUTHWESTERN file reference
UTSD:0893 HK);
m. Israeli
Patent Application Number 16526, effective filing date July 15, 2003, entitled
“Selected Antibodies and Duramycin Peptides Binding to Anionic Phospholipids and
Aminophospholipids and Their Use in Treating Viral Infections and Cancer” (UT
SOUTHWESTERN file reference UTSD:0893 IL);
n. Indian
Patent Application Number 416/DELNP/2005, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 IN);
o. Japanese
Patent Application Number 2004-521771, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 JP);
p. South
Korean Patent Application Number 2005-700602, effective filing date July 15,
2003, entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 KR);
q. Mexican
Patent Application Number PA/a/2005/000652, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 MX);
r. New
Zealand Patent Application Number 537690, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 NZ);
s. Singapore
Patent Application Number 200500378-5, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 SG);
t. South
African Patent Application Number 2005/0363, effective filing date July 15,
2003, entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 ZA);
u. U.S.
Patent Application Number 10/621,269, filed July 15, 2003, entitled “Selected
Antibody Compositions For Binding To Aminophospholipids” (UT SOUTHWESTERN file
reference UTSD:0893 US);
v. U.S.
Patent Application Number 10/620,850, filed July 15, 2003, entitled “Selected
Antibody Compositions and Methods For Binding To Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD:0893-1 US);
Exhibit 1
Page 2 of 3
w. U.S.
Patent Application Number 10/642,071, filed August 15, 2003, entitled “Cancer
Treatment Methods Using Selected Antibodies to Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD: 893-2 US);
x. U.S.
Patent Application Number 10/642,058, filed August 15, 2003, entitled “Combined
Cancer Treatment Methods Using Selected Antibodies to Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD:0893-3 US);
y. U.S.
Patent Application Number 10/642,118, filed August 15, 2003, entitled “Selected
Antibody CDRs for Binding To Aminophospholipids” (UT SOUTHWESTERN file reference
UTSD:0893-4 US);
z. U.S.
Patent Application Number 10/642,064, filed August 15, 2003, entitled “Liposomes
Coated with Selected Antibodies That Bind to Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD:0893-5 US);
aa. U.S.
Patent Application Number 10/642,116, filed August 15, 2003, entitled
“Combinations and Kits For Cancer Treatment Using Selected Antibodies to
Aminophospholipids” (UT SOUTHWESTERN file reference UTSD:0893-6
US);
bb. U.S.
Patent Application Number 10/642,099, filed August 15, 2003, entitled “Selected
Immunoconjugates for Binding To Aminophospholipids” (UT SOUTHWESTERN file
reference UTSD:0893-7 US);
cc. U.S.
Patent Application Number 10/642,065, filed August 15, 2003, entitled “Cancer
Treatment Methods Using Selected Immunoconjugates For Binding To
Aminophospholipids” (UT SOUTHWESTERN file reference UTSD:0893-8
US);
dd. International
Patent Application Number PCT/US03/21925, filed July 15, 2003, entitled
“Selected Antibodies & Duramycin Peptides Binding to Anionic Phospholipids
& Aminophospholipids & Their Use in Treating Viral Infections &
Cancer” (UT SOUTHWESTERN file reference UTSD:0893 WO);
ee. U.S.
Patent Application Number 10/642,059, filed August 15, 2003, entitled
“Compositions Comprising Cell-Impermeant Duramycin Derivatives” (UT SOUTHWESTERN
file reference UTSD:0968 US);
ff. U.S.
Patent Application Number 10/642,117, filed August 15, 2003, entitled
“Anti-Viral Treatment Methods Using Phosphatidylethanolamine-Binding Peptide
Derivatives” (UT SOUTHWESTERN file reference UTSD:0968-1 US);
gg. U.S.
Patent Application Number 10/642,121, filed August 15, 2003, entitled
“Compositions Comprising Phosphatidylethanolamine-Binding Peptides Linked to
Anti-Viral Agents” (UT SOUTHWESTERN file reference UTSD:0968-2 US);
and
hh. U.S.
Patent Application Number 10/642,100, filed August 15, 2003, entitled
“Anti-Viral Treatment Methods Using Phosphatidylethanolamine-Binding Peptides
Linked to Anti-Viral Agents” (UT SOUTHWESTERN file reference UTSD:0968-3
US).
Exhibit 1
Page 3 of 3
ROYALTY
REPORT
|
Period:
|
/ /
|
through
|
/ /
|
|
Licensee:_________________________________
|
Agreement
#: L0892.Peregrine$
|
|
If
license covers several product lines, please prepare a separate report for
each product line. Then combine all product lines into a
summary report.
|
|
Report
Type:
|
o Single
Product Line Report:
|
__________________________________________________
|
|
(Product
Name)
|
||
|
o Multi-Product
Summary Report (Page 1 of __ pages)
|
||
|
Country
|
Quantity
Produced
|
Gross
Sales
($)
|
*Less
Allowances
|
Net
Sales
($)
|
Royalty
Rate
|
Conversion
Rate
(if
applicable)
|
Royalties
Due
this
period(US$)
|
|
USA
|
|||||||
|
Canada
|
|||||||
|
Japan
|
|||||||
|
Other:
|
|||||||
|
Sublicensees:
|
|||||||
|
___________
|
|||||||
|
___________
|
|
Subtotal:
|
|
|
Less
Advanced Royalty Balance (if any):
|
|
|
TOTAL
ROYALTIES DUE THIS PERIOD:
|
* Please
indicate in the following space the specific types of deductions and the
corresponding amounts used to calculate Allowances:
|
Prepared
by --
|
Name:___________________________________________
|
|
Title:____________________________________________
|
|
|
Date:____________________________________________
|
Mail
completed report and royalty payment (make checks payable to: UT
SOUTHWESTERN) to:
UT
Southwestern Medical Center at Dallas
Office
for Technology Development
5323
Harry Hines Boulevard
Dallas,
Texas 75390-9094
ATTN: Director
for Technology Development
Exhibit 2
Page 1 of 1